In a prior
post (http://genpeace.blogspot.com.br/2012/04/what-is-lmogmo-not-likely-to-have.html) we discussed how to produce a
meaningful list of safe GMOs (transgenic organisms or LMOs). A more formal
approach to the problem of identifying safe LMOs was recently released by the Global
Industry Coalition (GIC). The Global
Industry Coalition (GIC) for the Cartagena Protocol on Biosafety receives input
and direction from trade associations representing thousands of companies from
all over the world. Participants include
associations representing and companies engaged in a variety of industrial
sectors such as plant science, seeds, agricultural biotechnology, food
production, animal agriculture, human and animal health care, and the
environment.
It is a
long text, but has very important information and a large set of references
that may be useful to support their claims and to foster new discussions on the
subject of biosafety. The full text is posted here.
30 April 2012
VIEWS ON THE IDENTIFICATION OF LIVING
MODIFIED ORGANISMS THAT ARE NOT LIKELY TO HAVE ADVERSE EFFECTS ON THE
CONSERVATION AND SUSTAINABLE USE OF BIOLOGICAL DIVERSITY, TAKING ALSO INTO
ACCOUNT RISKS TO HUMAN HEALTH
GLOBAL INDUSTRY COALITION
The Global Industry
Coalition (GIC)
is submitting the following information in relation to the request for
scientifically sound information on “the identification of living modified
organisms that are not likely to have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health.” This request from the
Secretariat is one of the provisions of the medium-term programme of work,
decision BS-I/12 paragraph 7 (a) (i) and is further elaborated in decision
BS-V/12 adopted by the fifth Conference of the Parties to the Convention on
Biological Diversity serving as the Meeting of the Parties to the Cartagena
Protocol on Biosafety (Nagoya, 11-15 October 2010).
Paragraphs IV.12 and 13 of BS-V/12 explicitly state:
12.
Requests Parties and invites other Governments and
relevant organizations to submit to the Executive Secretary (i) information on
risk assessments, carried out on a case-by-case basis with regards to the
receiving environment of the living modified organism, that might assist
Parties in the identification of living modified organisms that are not likely
to have adverse effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, and (ii) the
criteria that were considered for the identification of such living modified
organisms;
13. Requests
the Executive Secretary to compile the information received and prepare a
synthesis report for consideration by the Parties at their sixth meeting.
The GIC supports the efforts of the Secretariat
towards identification of LMO’s that are not likely to have adverse effects on
the conservation and sustainable use of biological diversity, taking also into
account risks to human health. With 27
years of global experience conducting risk assessments and a 17 year history of
safe commercial use, the GIC strongly believes that Parties should take
advantage of the full flexibility allowed by the Protocol in using existing
data, data sharing, and regional cooperation in the review and assessment of
available data to reduce unnecessary regulatory costs.
Introduction
The GIC welcomes the opportunity to share information on risks
assessments that have been conducted over the past 27 years, beginning in 1985
with the risk assessments that were conducted prior to the first field trials
of GM crops and bacteria. By 2011, 29
countries globally have commercialized GM crops and conducted the associated
risk assessments (ISAAA). It is notable
that in over 27 years of field trials in countries around the world, no reports
of adverse impacts to biodiversity have been confirmed based on routine
monitoring by regulatory authorities or in the scientific literature.
We believe that at this point, there are opportunities to realize
efficiencies in regulatory processes with respect to products that have been
commercialized across varied receiving environments, taking advantage of risk
assessments that have been conducted by regulatory authorities in other
jurisdictions and the body of scientific information that has been gathered on
the history of safe use. Particularly
for those products that have been approved for commercialization by numerous
regulatory authorities globally, we believe that it is not necessary to repeat
risk assessment de novo, which is needlessly costly and provide no increased
environmental protection.
Parties should be encouraged to find ways to utilize all available
information to assist with regulatory decision making in order to more
efficiently utilize the limited resources of regulatory authorities. Much information on existing environmental
risk assessments for currently commercialized products is already easily
available through the Biosafety Clearinghouse (e.g. http://bch.cbd.int/database/lmo/decisions.shtml?documentid=14750). Additional improvements to the operability of the Biosafety
Clearinghouse will assist in making relevant information available to
regulators. Further, the Cartagena
Protocol on Biosafety and the Convention on Biological Diversity both stress
the importance of transnational cooperation.
To this end, Parties may seek efficiencies in the review process through
cooperation on regional data reviews, while maintaining local decision making
authority.
The information provided in this submission updates previous submissions
by the GIC on Risk Assessment and Risk Management. In January 2009, the GIC submitted a
compilation of environmental risk assessment guidance, which also included
references and background information on risk assessment for crops, trees,
plant made pharmaceuticals and transgenic animals. In September 2009, the GIC submitted
information in relation to the request for scientifically sound information on
the identification of LMO’s or specific traits that may have adverse effects on
the conservation and sustainable use of biological diversity, taking also into
account risks to human health. This
submission included a lengthy bibliography of references on environmental risk
assessment.
The available scientific literature, as described in the current and
previous GIC submissions on Risk Assessment and Risk Management, supports the
conclusion that there are no confirmed adverse effects detected.
Transgenic Crops
Environmental
Risk Assessment for Field Trials of GM Crops in Select Countries
Australia: Since 1995, 93 licenses for intentional
release have been issued in Australia, most frequently for cotton which
accounts for 40 licenses. The next most
commonly tested crops were canola, wheat and barley. Information on the risk assessments that were
conducted prior to issuing licenses for deliberate release is available
at: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1.
European Union: Field testing began in the European Union in
1991. As of April 2012, over 2500 field
trials had been conducted with over 80 different plant species. Figure 2 shows the number of deliberate
releases in the EU for field trials by crop for the top ten most frequently
tested crops. Information on deliberate
releases in the EU for field trials is available at: http://mbg.jrc.ec.europa.eu/deliberate/gmo.asp.
India: Field trials have taken place in India since
1995. Detailed information is available
on field trials conducted since 2007, across a range of crops including cotton,
corn, rice, potato, brinjal (eggplant), okra, tomato, watermelon, sorghum,
mustard, sugarcane and others at: http://igmoris.nic.in/multiLocReTrail.asp.
United States: The first field trials of GM crops were
conducted in 1985 in the U.S. Since
then, nearly 18,000 field trials have been conducted in the U.S. under permit
or notification involving potentially millions of different transformation
events. Figure 1 shows the number of
releases by crop for the top ten most frequently tested crops. Information on the environmental risk
assessments that have been done prior to the issuance of field trial permits or
acknowledgments of notification is available at: http://www.aphis.usda.gov/brs/biotech_ea_permits.html.
Environmental Risk Assessment for Commercial
Release of GM Crops
It has been 20 years since the first biotechnology-derived (GM) crop was
granted deregulated status for environmental release in the United States. Over this time, significant experience has
been gained pointing to the safety of the GM crops assessed and approved for
environmental release. The GM Crop
Database (CERA, 2012) contains comprehensive records on regulatory approvals
for regulated crops. This database
currently shows that 125 unique products have been granted environmental release (See Table 1.) The environmental approvals encompass 20
species of plants, most of which are considered highly domesticated. According to the GM Crop Database, 313
separate environmental risk/safety assessments have been completed by
regulatory authorities globally. The
majority of these assessments have been conducted in the U.S. (82), Canada (72)
and Japan (56).
Several of these products have been subject to multiple environmental
assessments in the course of seeking approvals in various countries. A total of 14 products have been granted at
least five environmental approvals (Table 2), including four products which
have been granted approvals by 9 countries:
MON531/757/1076 (Bollgard® Cotton), GTS 40-3-2 (Roundup Ready® Soybean),
BT11 (X4334CBR, X4734CBR) (Agrisure CB Advantage®) and MON810 (Yieldgard®)
maize.
Detailed information on the risk assessments that have been done by
regulatory authorities in various countries is available on the following websites:
Figure 1. Total number of field trial releases for top
10 crops in the United States
Source: http://www.isb.vt.edu/release-summary-data.aspx
Figure 2.
Total number of field trials releases for top 10 crops in the European
Union
Table 1. Number of environmental assessments conducted globally by crop
Crop
|
# of Products Approved for Environmental Releasea
|
# of Environmental Assessments (approvals)
|
Trait(s)
HT-herbicide tolerance
IP-insect protected
MS-male sterility
QUAL-quality
VR-virus resistant
|
Notes
|
Alfalfa
|
1
|
2
|
HT
|
|
Canola
|
15
|
39
|
HT,
MS, QUAL
|
Brassica napa and B. rapa
|
Carnation
|
3
|
5
|
HT,
QUAL
|
|
Chicory
|
1
|
2
|
HT,
MS
|
|
Cotton
|
17
|
48
|
HT,
IP
|
Includes
5 stacked event products
|
Flax/Linseed
|
1
|
2
|
HT
|
|
Lentil
|
1
|
1
|
HT
|
Product
of mutagenesis
|
Maize
|
48
|
144
|
HT,
MS, QUAL, IP
|
3
products of mutagenesis; 18 stacked event products
|
Papaya
|
2
|
2
|
VR
|
|
Plum
|
1
|
1
|
VR
|
|
Potato
|
4
|
8
|
IP,
VR
|
4
different approvals for 20 unique events
|
Rice
|
2
|
2
|
HT
|
Does
not include Bt rice from China and Iran
|
Soybean
|
10
|
33
|
HT,
QUAL
|
|
Squash
|
2
|
2
|
VR
|
|
Sugar
Beet
|
3
|
6
|
HT
|
|
Sunflower
|
1
|
1
|
HT
|
Product
of mutagenesis
|
Tobacco
|
1
|
1
|
QUAL
|
|
Tomato
|
6
|
8
|
IP,
QUAL
|
5
delayed ripening products
|
Wheat
|
6
|
6
|
HT
|
Products
of mutagenesis
|
TOTAL
|
125
|
313
|
|
|
a Products
may include more than one event.
Table 2. Products with 5 or more
environmental assessments (approvals)
Crop
|
Product
|
Trait
|
# of Approvals
|
Countries
|
Cotton
|
MON15985
|
IP
|
6
|
Australia,
Brazil, Burkina Faso, India, South Africa, United States
|
|
MON1445/1698
|
HT
|
7
|
Argentina,
Australia, Brazil, Colombia,
Japan,
South Africa, United States
|
|
MON531/757/1076
|
IP
|
9
|
Argentina,
Australia, Brazil, Colombia, India, Japan, Mexico, South Africa, United
States
|
Corn/Maize
|
176
|
IP
|
5
|
Argentina,
Canada, European Union, Japan, United States
|
|
Bt11
|
IP
|
9
|
Argentina,
Brazil, Canada, Colombia, Japan, Philippines, South Africa, United States,
Uruguay
|
|
GA21
|
HT
|
7
|
Argentina,
Brazil, Canada, Japan, Philippines, United States, Uruguay
|
|
MON810
|
IP
|
9
|
Argentina,
Brazil, Canada, European Union, Japan, Philippines, South Africa, United
States, Uruguay
|
|
Bt11xGA21
|
IP
x HT
|
5
|
Argentina,
Brazil, Canada, Japan, Uruguay
|
|
MIR162
|
IP
|
5
|
Argentina,
Brazil, Canada, Japan, United States
|
|
MON89034
|
IP
|
5
|
Argentina,
Brazil, Canada, Japan, United States
|
|
NK603
|
HT
|
8
|
Argentina,
Brazil, Canada, Japan, Philippines, South Africa, United States, Uruguay
|
|
NK603xMON810
|
IP
x HT
|
7
|
Argentina,
Brazil, Canada, Japan, Philippines, South Africa, Uruguay
|
|
T14,
T25
|
HT
|
6
|
Argentina,
Brazil, Canada, European Union, Japan, United States
|
|
TC1507
|
IP,
HT
|
6
|
Argentina,
Brazil, Canada, Japan, United States, Uruguay
|
Transgenic Trees
Environmental
Risk Assessment for Field Trials
The most comprehensive review of the status
of trasgenic trees was prepared by the Food and Agricultural Organization,
which conducted a survey in 2003. At
that time, 27 countries reported approved field trials of transgenic trees of either
forest or tree species. (See Table
3.) An updated summary of the status of
field tests with transgenic trees for select countries is provided in Table 4.
Environmental
Risk Assessment for Commercial Release
Two countries, the United States and China,
have approved the commercial release of transgenic trees, as follows.
China is the only country to approve
commercial planting of transgenic forest trees.
It is reported that 1.4 million Bt poplar trees have been planted on an
area of 300-500 hectares, with an associated refuge for insect resistance
management. The oldest trees are now
more than 15 years old (Walter, et al. 2010).
In addition, it is estimated that 99% of papaya on over 5000 hectares
are planted with virus resistant papaya (ISAAA).
Two transgenic tree species have completed
the necessary regulatory reviews in the U.S.:
virus resistant papaya and virus resistant plum. Virus resistant papaya was commercially
deployed in 1998, protecting the Hawaiian papaya industry from the threat of
papaya ringspot virus. A second virus
resistant papaya variety for cultivation in the state of Florida completed
regulatroy review in 2009. Virus
resistant plum is not yet commercialized, as the plum pox disease to which it
is resistant has not become established in the U.S. Information on the risk assessments that were
conducted for these two technologies are available at: www1.usgs.gov/usbiotechreg/.
Table 3. Summary of reported
field trials of transgenic trees from 2003 FAO Survey
Field Trials Reported
|
Genus/Species Assessed
|
Traits Involved
|
Australia
Belgium
Brazil
Canada
Chile
China
Finland
France
Germany
India
Indonesia
Ireland
Israel
Italy
Japan
Mexico
Netherlands
New Zealand
Norway
Portugal
South Africa
Spain
Sweden
Thailand
United Kingdom
United States
Uruguay
|
Forest Trees:
Eucalyptus
Populus
Picea
Pinus
Betula
Fruit Trees:
Carica papaya
Malus
Olea
Prunus
Cyphomandra
Juglans
Belladonna
Citrus
Persea
Castanea
|
Reporter and marker genes
Fruit ripening
Viral resistance
Fungal resistance
Herbicide resistance
Lignin modification
Nitrate reductase synthesis
Metabolites
Heavy metal phytoremediation
Bacterial resistance
Salt resistance
Rooting
Altered ethylene production
Plant development
Altered sugar alcohol levels
Metabolism of halogenated
hydrocarbons
Sterility
Altered fruit ripening
Altered gene expression
Altered polyphenol oxidase
levels
Changes in reproduction (not
sterility)
Insect resistance
Sugar content
|
Source: FAO,
2004, Preliminary review of biotechnology in forestry including genetic
modification, Forest Genetic Resources Working Paper 59.
(http://www.fao.org/docrep/008/ae574e/ae574e00.htm)
Table 4. Summary of field trials for transgenic trees
and other woody perennials in selected countries
Country
|
# of Permits
|
Species
|
Argentina
|
7
|
Orange
|
Australia
|
8
|
banana, rose,
grape, papaya
|
Canada
|
72
|
poplar,
spruce, grape, cherry
|
EU
|
>80
|
>25
species
|
US
|
>750
|
>50
species
|
Plant-Made Pharmaceuticals
Since 2004, USDA has issued over 100 permits
for the confined release of plants genetically engineered to produce
pharmaceuticals, industrials, value added proteins or for phytoremediation
(Table 5). It is likely that plant made pharmaceuticals will
remain regulated, requiring a permit for environmental release in the United
States, even for commercial production. . An annex to the GIC’s 2009
submission on environmental risk assessment provided an overview of how some
selected countries have adapted existing risk management practices for the
conduct of confined field trials to enable the safe production of PMP’s under
confined, or closed-loop, production systems.
Table 5 provides up to date information on release permits issued by the
US Department of Agriculture Animal and Plant Health Inspection Service for
Pharmaceuticals, Industrials, Value Added Proteins for Human Consumption or for
Phytoremediation, as of April 5, 2012.
Transgenic Animals,
Including Fish
Also in an annex to the GIC’s 2009 submission
on environmental risk assessment was an overview of the regulatory and review
procedures of selected countries as they apply to the environmental risk
assessment of transgenic animals including fish. Since that submission, the US Food and Drug
Administration completed an environmental assessment of a goat genetically
engineered to produce recombinant human antithrombin III (rhAT), a therapeutic
protein for treatment of congenital Antithrombin III deficiency, a
life-threatening condition causing clot formation during high risk situations
such as surgery and obstetrical procedures.
Information on the environmental approval is available at: http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM163814.pdf
In September 2010, the US Food and Drug Administration
held a public meeting to review data relevant to the safety and effectiveness
concerning a genetically engineered salmon intended to grow faster than
conventional bred Atlantic salmon. In
conjunction with this meeting, the US Food and Drug Administration released an
environmental assessment submitted by the sponsor of the application. It is available at:
Table 5. Number of release
permits issued by USDA for plants genetically engineered to product
pharmaceutical and industrial compounds
Year
|
Pharmaceuticals, Industrials and Value Added Proteins
|
Phytoremediation
|
2004
|
11
|
5
|
2005
|
13
|
1
|
2006
|
11
|
1
|
2007
|
11
|
1
|
2008
|
8
|
2
|
2009
|
10
|
1
|
2010
|
11
|
1
|
2011
|
10
|
1
|
2012a
|
6
|
1
|
Totals
|
91
|
14
|
a As
of April 5, 2012. Includes permits that
are issued or pending.
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Recent Scientific Literature Relevant to
Environmental Risk Assessment of Transgenic Trees
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Recent Scientific References Relevant to
Environmental Risk Assessment of Transgenic Animals
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transgenic organisms: a growth-enhanced salmon simulation. Transgenic Research, 20,
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